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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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FDA Defends Plans to Regulate LDTs at House Hearing

Posted 17 November 2015 | By Michael Mezher

The US Food and Drug Administration (FDA) is making it clear to Congress that it's up to the task of regulating lab developed tests (LDTs).

Speaking at a House Energy & Commerce Committee hearing today, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH) defended the agency's plan saying, "Getting the right treatment to the right patient at the right time depends on having accurate, reliable and clinically validated tests."

In 2014, FDA announced it would no longer exercise its enforcement discretion on LDTs, saying it would regulate the tests as medical devices, similar to how the agency regulates in vitro diagnostics (IVDs).

Committee Hearing

Kicking off the hearing, Committee Chairman Joseph Pitts (R-PA) said: "I'm far less interested in litigating the boundaries of current FDA or CMS legal authority, than in hearing from our witnesses about how such authority could be clarified or improved."

Ahead of the hearing, the Energy & Commerce Committee released a draft discussion bill that echoes many of the principles contained in FDA's draft guidance, including that "FDA would regulate test development activities in a risk-based manner, and CMS would regulate lab operations."

However, some members argued against FDA increasing its oversight of LDTs. Rep. Michael Burgess (R-TX) said FDA's proposal would "stifle" innovation, saying it is "crucial that we do not slow innovation or create unnecessary regulatory hurdles … requiring premarket review by the FDA will impose new and arguably unnecessary requirements and costs on clinical laboratories, hospitals and doctors."

Other proposals have suggested dividing oversight of LDTs between FDA and CMS based on the type of test. Shuren rejected this approach, saying "such a system is going to lead to inefficiencies. It's going to lead to inconsistent standards treating the same test differently depending upon who makes the test … if we're going to assure that tests work we need one unified system."

Shuren also highlighted the importance of having one agency tasked with reviewing LDTs, saying "when someone makes a test and another lab … makes a similar test we learn from that and sometimes identify … common problems and … feed that back to test developers … if you split it between two different agencies we're going to lose all that learning."

When asked what standard FDA would hold LDTs to, Shuren said the agency "would apply the same standard we apply to in vitro diagnostic tests that are not made by a lab."

Risks Posed by LDTs

Responding to these concerns, Shuren pointed members to a report issued by FDA on Monday which highlighted 20 cases where LDTs posed a direct risk to patients when they did not meet their performance specifications.

Shuren also said that detecting issues with LDTs is difficult because the agency does not have systems in place to monitor the tests. However, he said that for some already cleared LDTs, their developers "started to identify problems [after] they put in the systems … in place."